Peripheral Arterial Disease
Conditions
Brief summary
This study will validate the efficacy and safety of the VESTO® Vascular Stent for treating patients with iliac peripheral arterial obstructive disease in a post-market clinical trial
Detailed description
Multicenter study aimed at collecting post-market clinical data on the VESTO® vascular stent for the treatment of patients with iliac peripheral arterial occlusive disease requiring endovascular intervention. The objective of the study is to evaluate the short-term (12-month) safety and clinical performance of the Vesto® vascular stent in patients with iliac peripheral arterial occlusive disease.
Interventions
DEVICEVascular Stent - Vesto Endoprosthesis
Vascular Stent Implant - Vesto Endoprosthesis
Sponsors
Braile Biomedica Ind. Com. e Repr. Ltda.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 18 years of age or older; 2. TASC-II aortoiliac lesion classification of modified class A, B, C, or D; 3. Rutherford classification score of 2 to 5; 4. Access site compatibility with the device delivery system; 5. Compliance with the device's instructions for use (IFU); 6. Patient availability for appropriate follow-up times for the duration of the study; 7. Patient informed about the nature of the study, agreeing to its provisions, and signing the informed consent form.
Exclusion criteria
1. Known hypersensitivity to heparin, contrast media, or stent components; 2. Patient with blood dyscrasia; 3. Pregnant or breastfeeding women; 4. Patient currently participating in an investigational drug or device study; 5. Patient undergoing chemotherapy or radiation therapy; 6. Patient with a stent or graft located in the target limb; 7. Patient who underwent angioplasty or bypass surgery within 30 days prior to inclusion in this study; 8. Patient with a life expectancy of less than 12 months; 9. Inability to undergo dual antiplatelet therapy (DAPT)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Device-Related Serious Adverse Events (Device Safety) | 30 days post-index procedure | Absence of major serious adverse events occurring within 30 days after the index procedure, defined as device- or procedure-related death, acute myocardial infarction (AMI), or above-the-metatarsal amputation in the treated leg due to a vascular event |
| Number of Patients with Technical Success (Device Performance) | Intraoperative | Technical success with the absence of serious adverse events related to the device |
| Number of Patients Without Rupture or Dissection of the Treated Vessel (Combined Safety and Performance Outcome) | 30 days post index procedure | Absence of rupture or dissection of the treated vessel within 30 days after the procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Conversion Rate to Open Surgery | Intraoperative | Rate of patients who required conversion to open surgery |
| Primary Patency Rate | 30 days post index procedure | Defined as the absence of restenosis \> 50% within 30 days |
| Number of Patients with Clinical Success | 30 days, 3, 6, 9, and 12 months | Defined by symptom improvement |
| Rate of Technical Success | Intraoperative | Defined as the successful deployment of the endoprosthesis at the intended site with patency and absence of significant device deformities (e.g., kinks, stent eversion, twisting) |
| Limb Salvage Rate | 30 days, 6, 9, and 12 months | When patients with rest pain experienced pain relief and those with foot ulcers showed improved perfusion, avoiding the need for amputation |
| Need for Endovascular Reintervention at the Target Lesion | 30 days, 3, 6, 9, and 12 months | Percentage of patients who required additional endovascular procedures at the same anatomical site as the initial intervention |
| Rate of Target Vessel Patency | 3, 6, 9, and 12 months | Absence of restenosis \> 50% |
| Rate of Procedural Success | 30 days post index procedure | Defined as the absence of serious adverse events related to the device within 30 days |
| Incidence of Adverse Events | 30 days, 3, 6, 9, and 12 months | Defined as device- or procedure-related death, bleeding or hematoma, myocardial infarction (MI), thrombosis, arterial rupture or dissection, or amputation above the metatarsal in the treated leg due to a vascular event |
Countries
Brazil
Contacts
Primary ContactGlaucia Basso
Outcome results
None listed